Prescription Drug Information: Venlafaxine Hydrochloride (Page 6 of 11)

Nonteratogenic Effects

Neonates exposed to venlafaxine hydrochloride, other SNRIs (Serotonin and Norepinephrine Reuptake Inhibitors), or SSRIs (Selective Serotonin Reuptake Inhibitors), late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Such complications can arise immediately upon delivery. Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. These features are consistent with either a direct toxic effect of SSRIs and SNRIs or, possibly, a drug discontinuation syndrome. It should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome (see PRECAUTIONS, Drug Interactions, CNS-Active Drugs). When treating a pregnant woman with venlafaxine hydrochloride during the third trimester, the physician should carefully consider the potential risks and benefits of treatment (see DOSAGE AND ADMINISTRATION).

Labor and Delivery

The effect of venlafaxine hydrochloride on labor and delivery in humans is unknown.

Nursing Mothers

Venlafaxine and ODV have been reported to be excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from venlafaxine hydrochloride, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in the pediatric population have not been established (see BOX WARNING and WARNINGS, Clinical Worsening and Suicide Risk). Two placebo-controlled trials in 766 pediatric patients with MDD and two placebo-controlled trials in 793 pediatric patients with GAD have been conducted with venlafaxine hydrochloride extended-release capsules, and the data were not sufficient to support a claim for use in pediatric patients.

Anyone considering the use of venlafaxine tablets in a child or adolescent must balance the potential risks with the clinical need.

Although no studies have been designed to primarily assess venlafaxine hydrochloride extended-release capsule’s impact on the growth, development, and maturation of children and adolescents, the studies that have been done suggest that venlafaxine hydrochloride extended-release capsules may adversely affect weight and height (see PRECAUTIONS, General, Changes in Height and Changes in Weight). Should the decision be made to treat a pediatric patient with venlafaxine hydrochloride, regular monitoring of weight and height is recommended during treatment, particularly if it is to be continued long term. The safety of venlafaxine hydrochloride extended-release capsule treatment for pediatric patients has not been systematically assessed for chronic treatment longer than six months in duration.

In the studies conducted in pediatric patients (ages 6 to 17), the occurrence of blood pressure and cholesterol increases considered to be clinically relevant in pediatric patients was similar to that observed in adult patients. Consequently, the precautions for adults apply to pediatric patients (see WARNINGS, Sustained Hypertension and PRECAUTIONS, General, Serum Cholesterol Elevation).

Geriatric Use

Of the 2,897 patients in Phase 2 and Phase 3 depression studies with venlafaxine hydrochloride, 12% (357) were 65 years of age or over. No overall differences in effectiveness or safety were observed between these patients and younger patients, and other reported clinical experience generally has not identified differences in response between the elderly and younger patients. However, greater sensitivity of some older individuals cannot be ruled out. SSRIs and SNRIs, including venlafaxine hydrochloride, have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse event (see PRECAUTIONS, Hyponatremia).

The pharmacokinetics of venlafaxine and ODV are not substantially altered in the elderly (see CLINICAL PHARMACOLOGY). No dose adjustment is recommended for the elderly on the basis of age alone, although other clinical circumstances, some of which may be more common in the elderly, such as renal or hepatic impairment, may warrant a dose reduction (see DOSAGE AND ADMINISTRATION).

ADVERSE REACTIONS

Associated With Discontinuation of Treatment

Nineteen percent (537/2897) of venlafaxine patients in Phase 2 and Phase 3 depression studies discontinued treatment due to an adverse event. The more common events (≥ 1%) associated with discontinuation and considered to be drug-related (i.e., those events associated with dropout at a rate approximately twice or greater for venlafaxine compared to placebo) included:

*
Percentages based on the number of males.

CNS

Venlafaxine

Placebo

Somnolence

3%

1%

Insomnia

3%

1%

Dizziness

3%

Nervousness

2%

Dry mouth

2%

Anxiety

2%

1%

Gastrointestinal

Nausea

6%

1%

Urogenital

Abnormal ejaculation *

3%

Other

Headache

3%

1%

Asthenia

2%

Sweating

2%

— Less than 1%

Incidence in Controlled Trials

Commonly Observed Adverse Events in Controlled Clinical Trials

The most commonly observed adverse events associated with the use of venlafaxine hydrochloride (incidence of 5% or greater) and not seen at an equivalent incidence among placebo-treated patients (i.e., incidence for venlafaxine hydrochloride at least twice that for placebo), derived from the 1% incidence table below, were asthenia, sweating, nausea, constipation, anorexia, vomiting, somnolence, dry mouth, dizziness, nervousness, anxiety, tremor, and blurred vision as well as abnormal ejaculation/orgasm and impotence in men.

Adverse Events Occurring at an Incidence of 1% or More Among Venlafaxine Hydrochloride-Treated Patients

The table that follows enumerates adverse events that occurred at an incidence of 1% or more, and were more frequent than in the placebo group, among venlafaxine hydrochloride-treated patients who participated in short-term (4 to 8 week) placebo-controlled trials in which patients were administered doses in a range of 75 to 375 mg/day. This table shows the percentage of patients in each group who had at least one episode of an event at some time during their treatment. Reported adverse events were classified using a standard COSTART-based Dictionary terminology.

The prescriber should be aware that these figures cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those which prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and nondrug factors to the side effect incidence rate in the population studied.

TABLE 2: Treatment-Emergent Adverse Experience Incidence in 4 to 8 Week Placebo-Controlled Clinical Trials *
— Incidence less than 1%.
*
Events reported by at least 1% of patients treated with venlafaxine hydrochloride are included, and are rounded to the nearest %. Events for which the venlafaxine hydrochloride incidence was equal to or less than placebo are not listed in the table, but included the following: abdominal pain, pain, back pain, flu syndrome, fever, palpitation, increased appetite, myalgia, arthralgia, amnesia, hypesthesia, rhinitis, pharyngitis, sinusitis, cough increased, and dysmenorrhea3.
Incidence based on number of male patients.
Incidence based on number of female patients.

Body System

Preferred Term

Venlafaxine Hydrochloride (n = 1033)

Placebo (n = 609)

Body as a Whole

Headache

25%

24%

Asthenia

12%

6%

Infection

6%

5%

Chills

3%

Chest pain

2%

1%

Trauma

2%

1%

Cardiovascular

Vasodilatation

4%

3%

Increased blood pressure/hypertension

2%

Tachycardia

2%

Postural hypotension

1%

Dermatological

Sweating

12%

3%

Rash

3%

2%

Pruritus

1%

Gastrointestinal

Nausea

37%

11%

Constipation

15%

7%

Anorexia

11%

2%

Diarrhea

8%

7%

Vomiting

6%

2%

Dyspepsia

5%

4%

Flatulence

3%

2%

Metabolic

Weight loss

1%

Nervous System

Somnolence

23%

9%

Dry mouth

22%

11%

Dizziness

19%

7%

Insomnia

18%

10%

Nervousness

13%

6%

Anxiety

6%

3%

Tremor

5%

1%

Abnormal dreams

4%

3%

Hypertonia

3%

2%

Paresthesia

3%

2%

Libido decreased

2%

Agitation

2%

Confusion

2%

1%

Thinking abnormal

2%

1%

Depersonalization

1%

Depression

1%

Urinary retention

1%

Twitching

1%

Respiration

Yawn

3%

Special Senses

Blurred vision

6%

2%

Taste perversion

2%

Tinnitus

2%

Mydriasis

2%

Urogenital System

Abnormal ejaculation/orgasm

12%

Impotence

6%

Urinary frequency

3%

2%

Urination impaired

2%

Orgasm disturbance

2%

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